BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH MAC 3

    MDR report key: 2380586 · Received September 21, 2011

    Report

    Report Number
    3005416399-2011-00001
    Event Type
    Injury
    Date Received
    September 21, 2011
    Date of Event
    May 28, 2010
    Report Date
    September 16, 2011
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6) HOSPITAL, ON (B)(6) 2010. ANY POTENTIAL FOR THE SPLIT LINE ON THE MOULDED BLADE CONTRIBUTING TO TRAUMA OF THIS NATURE IN THE FUTURE WAS INVESTIGATED. ACTION WAS TAKEN TO ALTER THE MOULD TOOL AND MOULDING PROCESS TO REDUCE THE LIKELIHOOD OF FLASH ON THE SPLIT LINE AND AN INSPECTION STAGE WAS ADDED TO THE BATCH RELEASE PROCESS TO CHECK FOR ANY FEATURES THAT COULD CONTRIBUTE TO TRAUMA.

    Description of Event or Problem · 1

    THE PT WAS NOTED TO HAVE TRAUMA AT THE BACK OF THEIR MOUTH AFTER THE INTUBATION WITH A MAC3 LARYNGOSCOPE BLADE. THE BLOOD WAS NOTE AFTER THE INTUBATION AS THE DOCTOR DID AN ENT LIST AND USED THE SCOPE TO INSERT THROAT PACKING. ON THE SECOND INSERTION OF THE SCOPE THE TRAUMA WAS SEEN. LACERATION WAS NOTED AT THE BACK OF THE MOUTH OF THE SOFT PALATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGRATH MAC 3 LARYNGOSCOPE BLADE CCW AIRCRAFT MEDICAL LIMITED MAC3 AML08333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other